Status:
COMPLETED
Weight Loss Before Total Joint Arthroplasty Using A Remote Dietitian and Mobile App
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Vela Foundation
Conditions:
Arthroplasties, Replacement
Weight Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this trial is to assess the impact of a 12-week remote dietitian supervised dietary and physical activity weight loss intervention and mobile app for patients with morbid obesity prior ...
Detailed Description
Recruitment: Patients of orthopaedic surgeons (e.g. Dr. Antonia Chen, Dr. Jeffrey Lange, Dr. Vivek Shah, Dr. Richard Iorio and Dr. Wolfgang Fitz) at the Brigham and Women's Hospital or Mass General Ho...
Eligibility Criteria
Inclusion
- Subjects age \>= 18 years of age
- BMI \> 40 kg/m2 at study enrollment
- 3\. End-stage knee or hip osteoarthritis, avascular necrosis, or rheumatoid arthritis with recommended primary, unilateral total joint arthroplasty by orthopaedic surgeons at Brigham and Women's Hospital or Mass General Hospital (e.g. Dr. Antonia Chen, Dr. Jeffrey Lange, Dr. Vivek Shah, Dr. Richard Iorio and Dr. Wolfgang Fitz).
- Subject would consider undergoing a total joint arthroplasty if eligible.
- Owns a smartphone compatible with video calls and Nutrimedy (i.e. has access to Apple App Store or Google Play to download app) or has home internet access and a webcam for video calls.
- All subjects must be willing to comply with the requirements of the study and provide informed consent prior to enrollment. Evidence of a signed (by the research staff obtaining verbal consent) and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study must be obtained before data collection.
Exclusion
- BMI\>47 kg/m2 at study enrollment (BMI over 47 kg/ m2 would require inappropriate weight loss of over 3 lbs per week to reach a BMI of 40 kg/m2 after 12 weeks).
- Subjects unable to comprehend and speak English
- Subjects requiring a revision total joint arthroplasty
- Subjects undergoing bilateral total joint arthroplasty
- Subjects planning to undergo bariatric weight loss surgery in the next 6 months.
- Subjects planning to be pregnant in the next 6 months
- Subjects unwilling or unable to use a hand-held smartphone or personal computer with home internet access
- Incarcerated subjects
- Pregnant women and vulnerable individuals
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04330391
Start Date
July 1 2020
End Date
June 30 2024
Last Update
August 9 2024
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Faulkner Hospital
Boston, Massachusetts, United States, 02130